Manager, Clinical Study

Scope:

The Clinical Study Manager will be responsible for executing processes associated with ongoing and newly initiated clinical studies concerning molecular profiling of human cancers. The CSM will work closely with Assay Development, Pathology, and Laboratory Operations, as well as external clients to successfully implement and execute clinical trials on behalf of Interpace Diagnostics.

Essential Duties and Responsibilities:

• In-depth knowledge and understanding of the clinical study process
• Ability to critically evaluate clinical study protocol design and assist in protocol development
• Experience in managing multiple clinical studies including study sites, protocols, and data management
• Understanding of clinical study databases and how to interpret clinical study data
• Must be an effective communicator (both written and oral)
• Self-driven and independent work ethic with support of team leaders
• Able to lead participant meetings for trial implementation, execution and close out, including routine monitoring and planning.
• Support protocol development, assay development and manuscript writing with understanding of clinical trial data
• Working knowledge of clinical research processes and applicable local laws pertaining to clinical research investigations
  • Experience in protocol submission to IRB as well as coordination of submission with appropriate site staff
  • Experience with monitoring of clinical studies, including the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of data
  • Demonstrated experience with clinical trials software/reporting systems
• Curious about underlying biological/clinical hypothesis, assay technologies, and limitations (both in biology and assay technology).
• Demonstrated interpersonal, written, and oral communication skills, especially with key opinion leaders (KOL’s)
• Ability to identify issues proactively, identify resolutions and drive projects to completion

Additional Skills and Abilities:

• Exhibits a solid knowledge base of medical terminology and clinical endpoints related to cancer and molecular biology; knowledge of pathology related data a plus
• Ability to perform basic statistical analyses a plus
• Strong attention to detail and accuracy with excellent organizational skills.
• Ability to self-motivate and work independently.
• Demonstrated ability to multi-task and problem solve.
• Able to follow instructions and management direction.
• Strong computer skills with emphasis on effectively working with Microsoft Office products and Laboratory Information Systems (LIMS, or similar information systems database).

Education and/or Experience:

• MS in life sciences, public health, or biostatistics; OR
  1. BSN with extensive experience in clinical research coordination; OR
  2. BS degree in life sciences, biology or scientific practice with equivalent combination of education and work experience, including 5+ years of experience managing clinical research studies/data
• 3-5 years managing clinical research trials from implementation to close out
• Experience in a molecular lab, oncology or general laboratory preferred
• Experience and ability to perform statistical analyses preferred

Work Environment and Physical Demands:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work may require sitting for long periods of time; also stooping, bending and stretching for files and supplies. Work may require using stairs to access other departments when necessary. Occasionally lifting files or paper weighing up to 30 pounds. Requires manual dexterity sufficient to operate a keyboard, operate a calculator, telephone, copier and other such office equipment. It is necessary to view and type on computer screens for prolonged periods of time.